Systematic Evaluation of Mobile Applications for Informal Caregivers of People Living With Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of two currently available apps for unpaid caregivers of people living with dementia.
详细描述
Informal caregivers of people living with dementia experience stressors that are associated with adverse health outcomes. Mobile applications (i.e., apps) could potentially improve the delivery and increase access to interventions. Although apps for informal caregivers of people living with dementia are available, empirical evidence to support their effectiveness is limited. The evaluation will be conducted by recruiting informal caregivers of people living with dementia. Participants will be randomly assigned to one of the two app-using groups or a wait-list condition. In the rare event that a participant experiences issues downloading an assigned app (and before commencing the 2-week period), participants will be randomly assigned to one of the other two conditions. Participants in the app-using groups will be asked to use their app for a 2-week period, and burden, stress, overall health, and knowledge will be assessed before, after the 2-week period, and at a 3-week follow-up. Subjective app ratings and usability of apps will be collected after the 2-week period. A 3 between (group) by 3 within (time: baseline, post, follow-up) mixed model (repeated measures) multivariate analysis of variance and univariate analyses will be conducted to examine improvements on outcome measures over time. Interviews will be conducted, and textual data will be analyzed thematically to examine caregiver experiences, perceptions of caregivers in using selected apps, and preferences and needs of caregivers in the development of future apps. Findings from the proposed investigation can help guide caregivers in choosing the apps that best address their needs. Moreover, findings from the investigation can inform future developments of apps to address the needs of caregivers of people living with dementia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •providing informal care for a person living with dementia (e.g., informal caregivers who are non-professionals; this may include immediate family members such as spouses, children, and other relatives, friends)
- •living with or providing primary care for the person living with dementia (i.e., the care recipient is not in a long-term care facility)
- •providing unpaid care
- •own a smartphone (i.e., an iPhone or Android and/or can access either IOS or Android platforms)
排除标准
- •- using an app for caregiver stress/burden
研究组 & 干预措施
Dementia Talk
Participants in this group will be asked to use the mobile app Dementia Talk over a 2-week period.
干预措施: Dementia Talk mobile application (Other)
CLEAR Dementia Care
Participants in this group will be asked to use the mobile app CLEAR Dementia Care over a 2-week period.
干预措施: CLEAR Dementia Care mobile application (Other)
Waitlist Control Group
Participants in this group will not use any of the apps.
结局指标
主要结局
Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at 2 weeks
时间窗: The ZBI will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from baseline in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
时间窗: The ZBI will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from after the 2-week period in the Zarit Caregiver Burden Interview (ZBI) total scores at a 3-week follow up period
时间窗: The ZBI will be administered after a 2-week period and at a 3-week follow-up period.
Caregiver burden will be assessed using the ZBI. The ZBI is a 22-item self-report questionnaire designed to measure the extent of the burden experienced by the caregivers in various dimensions (e.g., health, psychological well-being, finances, social) of their lives as a result of caregiving. Each item is rated on a Likert scale ranging from 0 (Never) to 4 (Almost always) and indicates how often the caregiver has experienced the described situation. A total score ranging from 0 to 88 is calculated with increasing scores indicating greater burden experienced.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at 2 weeks
时间窗: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Change from baseline in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
时间窗: The DKAT2 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at 2 weeks
时间窗: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from baseline in the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
时间窗: The PSS-10 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from after a 2-week period on the Perceived Stress Scale-10 (PSS-10) total scores at a 3-week follow up period
时间窗: The PSS-10 will be administered after a 2-week period and at a 3-week follow-up period.
Perceived stress over the course of the intervention will be assessed using the PSS-10. The PSS-10 is a 10-item self-report questionnaire designed to measure general feelings of stress and overload in the past four weeks. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Very often). A total score ranging from 0 to 40 is calculated with increasing scores indicating greater stress.
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at 2 weeks
时间窗: The SF-12 will be administered at baseline (i.e., prior to starting the study) and immediately after the end of the intervention period (i.e., after a 2-week period).
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from baseline in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
时间窗: The SF-12 will be administered at baseline (i.e., prior to starting the study) and at a 3-week follow-up period.
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from after a 2-week period in the Short-Form Health Survey-12 (SF-12) scores at a 3-week follow up period
时间窗: The SF-12 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Overall well-being will be assessed using the SF-12. The SF-12 was derived from the original 30-item scale and is a self-report questionnaire that measures two dimensions of overall health: physical and mental. Accordingly, the scale consists of a Physical Component (SF-PC) and a Mental Component (SF-MC). Each item in the SF-12 is scored according to the scale's scoring algorithm and combined for each subscale. Total and subscale (SF-PC and SF-MC) scores range from 0 to 100, with increasing normed scores indicating better health and a score of 50 is average.
Change from after a 2-week period in the Dementia Knowledge Assessment Tool Version 2 (DKAT2) total scores at a 3-week follow up period
时间窗: The DKAT2 will be administered immediately after the end of the intervention period (i.e., after a 2-week period) and at a 3-week follow-up period.
Knowledge about dementia will be assessed using the DKAT2. DKAT2 is a 21-item self-report questionnaire designed to assess overall knowledge about dementia and dementia care among caregivers and health care staff. The DKAT2 expands from the previous DKAT version (i.e., DKAT1) by including items that are also be pertinent to family members and informal caregivers of people with dementia. Thirteen items in the scale are correct and eight items are incorrect. As such, reversal ratings are required and a score is calculated by summing the total number of correct responses ranging from 0 to 21, with higher scores indicating greater overall knowledge about dementia.
次要结局
- Total Mobile App Rating Scale Subjective App Quality score after the 2 week period(The MARS Subjective App Quality Rating will be administered after the end of the intervention period (i.e., after a 2-week period) for app-using participants.)
- Total System Usability Scale (SUS) score after the 2 week period(The SUS will be administered after the end of the intervention period (i.e., after a 2 week period) for app-using participants.)